NCT01344785

Brief Summary

The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

April 28, 2011

Last Update Submit

October 21, 2013

Conditions

Intertrochanteric Fractures

Keywords

Intertrochanteric FracturesIntramedullary nailingHip functionPain

Outcome Measures

Primary Outcomes (1)

  • Hip function

    1 year

Study Arms (1)

Patients with a intertrochanteric fracture

Patients with a intertrochanteric fracture, n=100

Procedure: Intramedullary nailing

Interventions

Intramedullary nailingPROCEDURE

All patients will be treated with Intramedullary nailing

Also known as: Gamma 3, Stryker, USA
Patients with a intertrochanteric fracture

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden

You may qualify if:

  • Intertrochanteric Fracture
  • Age over 55
  • Intramedullary nailing

You may not qualify if:

  • Severe cognitive impairment
  • Substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Hip FracturesPain

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Max Gordon, MD

    Danderyd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic surgeon

Study Record Dates

First Submitted

April 28, 2011

First Posted

April 29, 2011

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

SE(1)